Active Ingredients
Methyl Salcylate 20.000%
Menthol 10.00%
Capsalcin 0.025%
Exoten-c Lotion
FDA Label NDC 76420-947
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Asclemed Usa, Inc. for the product Exoten-c (NDC 76420-947). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, indications, warnings, otc - ask doctor, otc - keep out of reach of children, otc - do not use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Topical Analgesic
Topical Analgesic
Indications
For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.
Warnings
For external use only. Avoid contact with eyes.
Otc - Ask Doctor
If symptoms persist for more than seven days, discontinue use and consult physician.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, consult physician.
Otc - Do Not Use
Do not apply to wounds or damaged skin. Do not bandage tightly.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, contact physician prior to use.
Directions
Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
Children under two-years of age consult a physician.
Additional Information
Store at room temperature.
Other Ingredients
Aloe Barbadensis Leaf (Aloe Vera Gel); Aqua (Deionized Water); Arnica Montana Flower Extract; Carmober, Cetearyl Alcohol, Ethylexyl Palmitate, Glyceryl Stearate, Methylisothiazolinone, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Triethanolamine.
Principal Display Panel - Exoten-C Label
Exoten-C
Pain Relief 
Lotion
113.4 g
Distributed by Enovachem™
PHARMACEUTICALS
Torrance, CA 90501
(310) 320-0100
Principal Display Panel (Exoten-C Label)
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